Trial Outcomes & Findings for Id-KLH Vaccine + T Cells in Subjects With Myeloma Undergoing Transplant (NCT NCT01426828)
NCT ID: NCT01426828
Last Updated: 2020-12-04
Results Overview
Evaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28 activated autologous lymphocytes. RNA was isolated from CD4 and CD8 T cells pre-vaccine, and at day 30, 90 and 180 post-vaccine for gene expression analysis. The Nanostring Human immunology V2 kit, a multiplex assay for 594 genes involved in the human immunology response, was used with an nCounter digital analyzer to quantify immune response gene expression levels. Subjects were considered to have Id-specific immunity if they induced expression of effector (TBX21, KLRG1) and memory (CCL5) associated genes in CD8 T cells in post-vaccine time-points compared to baseline.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
40 participants
Primary outcome timeframe
180 DAYS
Results posted on
2020-12-04
Participant Flow
Participant milestones
| Measure |
Arm A
Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine.
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
Arm B
Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
|---|---|---|
|
Overall Study Evaluations
STARTED
|
22
|
18
|
|
Overall Study Evaluations
COMPLETED
|
17
|
15
|
|
Overall Study Evaluations
NOT COMPLETED
|
5
|
3
|
|
Immune Response Analysis
STARTED
|
17
|
15
|
|
Immune Response Analysis
COMPLETED
|
8
|
8
|
|
Immune Response Analysis
NOT COMPLETED
|
9
|
7
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Id-KLH Vaccine + T Cells in Subjects With Myeloma Undergoing Transplant
Baseline characteristics by cohort
| Measure |
Arm A
n=22 Participants
Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine.
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
Arm B
n=18 Participants
Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
Total
n=40 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
13 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
23 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
19 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 180 DAYSEvaluate whether infusions of Id-KLH primed CD3/CD28 activated autologous lymphocytes mediate a more intense Id-specific immunity than non Id-KLH primed CD3/CD28 activated autologous lymphocytes. RNA was isolated from CD4 and CD8 T cells pre-vaccine, and at day 30, 90 and 180 post-vaccine for gene expression analysis. The Nanostring Human immunology V2 kit, a multiplex assay for 594 genes involved in the human immunology response, was used with an nCounter digital analyzer to quantify immune response gene expression levels. Subjects were considered to have Id-specific immunity if they induced expression of effector (TBX21, KLRG1) and memory (CCL5) associated genes in CD8 T cells in post-vaccine time-points compared to baseline.
Outcome measures
| Measure |
Arm A
n=8 Participants
Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine.
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
Arm B
n=8 Participants
Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
|---|---|---|
|
Participants With Id-specific Immunity
|
0 Participants
|
8 Participants
|
Adverse Events
Arm A
Serious events: 6 serious events
Other events: 20 other events
Deaths: 0 deaths
Arm B
Serious events: 4 serious events
Other events: 16 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Arm A
n=22 participants at risk
Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine.
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
Arm B
n=18 participants at risk
Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
|---|---|---|
|
Metabolism and nutrition disorders
Dehydration
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Diarrhea
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
General disorders
Fever
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Injury, poisoning and procedural complications
Fracture
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Infections and infestations
Infections and infestations - Other (Influenza A)
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Infections and infestations
Lung infection
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Neutrophil count decreased
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Platelet count decreased
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other (Sweet's syndrome)
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Infections and infestations
Upper respiratory infection
|
4.5%
1/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
5.6%
1/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
Other adverse events
| Measure |
Arm A
n=22 participants at risk
Arm A will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of "KLH only" vaccine.
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
Arm B
n=18 participants at risk
Arm B will receive the CD3/CD28 activated autologous lymphocytes intravenously and subcutaneous injections of ID-KLH Vaccine Myeloma Immunoglobulin Idiotype Vaccine (id-KLH vaccine)
CD3/CD28: CD3/CD28 activated autologous lymphocytes intravenously
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
50.0%
11/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
38.9%
7/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Metabolism and nutrition disorders
Anorexia
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
22.2%
4/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
18.2%
4/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
General disorders
Chills
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Constipation
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
22.2%
4/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
18.2%
4/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Diarrhea
|
50.0%
11/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
66.7%
12/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Edema limbs
|
22.7%
5/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Fatigue
|
50.0%
11/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
55.6%
10/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
18.2%
4/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
General disorders
Fever
|
27.3%
6/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
33.3%
6/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
General disorders
General disorders and administration site conditions - Other (Achiness at injection site)
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
General disorders
General disorders and administration site conditions - Other (Body aches)
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Musculoskeletal and connective tissue disorders
Generalized muscle weakness
|
22.7%
5/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
16.7%
3/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Nervous system disorders
Headache
|
18.2%
4/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
27.8%
5/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
27.8%
5/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Metabolism and nutrition disorders
Hypomagnesemia
|
18.2%
4/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Metabolism and nutrition disorders
Hypophosphatemia
|
13.6%
3/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Vascular disorders
Hypotension
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Infections and infestations
Infections and infestations - Other (C.Diff)
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
General disorders
Injection site reaction
|
27.3%
6/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
22.2%
4/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Psychiatric disorders
Insomnia
|
22.7%
5/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Lymphocyte count decreased
|
27.3%
6/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
16.7%
3/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Mucositis oral
|
27.3%
6/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
33.3%
6/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Nausea
|
68.2%
15/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
66.7%
12/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Neutrophil count decreased
|
36.4%
8/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
33.3%
6/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Oral pain
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
General disorders
Pain
|
22.7%
5/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Infections and infestations
Papulopustular rash
|
13.6%
3/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
22.2%
4/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Platelet count decreased
|
54.5%
12/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
55.6%
10/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Infections and infestations
Upper respiratory infection
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Vomiting
|
31.8%
7/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
44.4%
8/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Weight gain
|
9.1%
2/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
0.00%
0/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
White blood cell decreased
|
59.1%
13/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
38.9%
7/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
16.7%
3/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Investigations
Blood bilirubin increased
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Gastrointestinal disorders
Esophagitis
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
0.00%
0/22 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
11.1%
2/18 • 1 year
The adverse event data included below reflects all data that can currently be verified by the sponsor. There is additional data that has yet to be verified by the investigator that will be included when available.
|
Additional Information
CCI @ University of Pennsylvania
University of Pennsylvania
Phone: (215)662-4000
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place